BN II System

BN II Systemm
Built on proven nephelometric experience. Designed for the future.

BN II System connectivity to Aptio Automation video

Watch a video to see the BN II System connected to lab automation to improve laboratory workflow.

The BN™ II System is a fully automated nephelometric analyzer that offers a broad range of protein assays. With assays available across multiple sample types, you can conveniently assess numerous disease states such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse—on just one system.

Designed for mid- to high-volume plasma protein throughput
Broad menu from one source; more than 70 assay protocols available for determination of various sample types
Up to 100 samples onboard
Antigen-excess security for confidence in results
Connectivity options to Aptio^® Automation and FlexLab Automation solutions

New Software Features

Expand to learn about the new software features in the BN II System.

: New features include:
GDPR compliance
The system’s user management software complies with data privacy laws and regulations, including the General Data Protection Regulation (GDPR). You can configure user privileges in accordance with these regulations, and private and patient data cannot be viewed or exported by unauthorized persons.
Audit trail
You can now easily track user activity related to generated results in compliance with the FDA CFR 21 part 11 regulation. You can also make comments on user activity if necessary. The log files can be exported and printed.
Improved user-management interface
User management has been changed to comply with industry standards. Rather than the previously role-based user management, all users now have individual login accounts with configurable privileges and electronic signature trails (required for audit trail purposes). This improved user management makes the system more secure and helps prevent unauthorized access.
Traceability
A new traceability feature allows you to trace a variety of information related to individual results, including the standards, calibration curves, framing controls, the operator performing the test, and more. This makes it easier to find specific lot numbers for sample results, either in the system or stored in the archive. The additional data that can now be viewed on a separate screen in the user interface improves overall searchability, the ability to use test result data, and system walkaway time. Results are now automatically stored in the system without the need for manual backup.

Features & Benefits

Transforming care delivery through optimized clinical operations

The BN™ II System provides flexible options to meet the needs of the mid- to high-volume plasma protein lab.

Free light chain testing using nephelometry recommended by the IMWG guidelines.

Improved specialty protein testing workflow with less operator hands-on time.

Enhanced workflow efficiency through ability to connect to Aptio® Automation and FlexLab Automation solutions.

BN II System allows you to save up to 36% operator hands-on time in specialty protein testing.

More than 70 programmed assay protocols (varies by country).

High, 100-sample onboard capacity and continuous loading for uninterrupted workflow.

Maximum throughput up to 225 tests per hour (average 130 tests per hour).

Welcome to the BN II System demo!

Learn more about the BN™ II System, a high-volume nephelometric specialty protein analyzer for protein determination in the clinical management of a variety of disease states, such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse.

BN II System

As the first dedicated protein analyzer that can be connected to lab automation, the BN™ II System provides flexible options to meet the needs of the mid- to high-volume plasma protein lab. It uses nephelometric technology for protein determination and supports the clinical management of a variety of disease states, such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse.

Enhance clinical support capabilities with a growing and innovative assay menu.

Features the industry’s largest nephelometric menu of more than 70 plasma protein assays.^†
Consolidates specialty and routine parameters on one system, supporting comprehensive disease state management and reducing send-outs.
Flexible testing options enable testing on serum, urine, plasma, and CSF.

Streamline lab workflows with high throughput, flexible configuration, and less hands-on time.

Load up to 100 samples to reduce hands-on time.
Connects to Aptio Automation to increase walkaway time.
Quick sample release allows additional testing without delays.
Provides average effective throughput of approximately 130 tests/hour.
Continuous loading of samples and reagents at any time supports improved testing workflow and less downtime.

Operate confidently with intuitive, state-of-the-art software.

State-of-the-art software and user management provide a high level of data privacy.
Software includes a state-of-the-art, comprehensive audit trail that complies with FDA CFR part 11.
Comprehensive software traceability features include tracking of assays and consumables.
Seamlessly integrates into the laboratory’s IT ecosystem, with connectivity to Atellica® Data Manager and Atellica Process Manager.^†
Provides optional clinical decision support using the PROTIS® IT Software Solution.

Test with high precision using sensitive, nephelometric technology.

Proven nephelometric technology offers high precision and reproducibility.
Sophisticated antigen-excess pre-reaction protocols provide more-accurate results and fewer repeats.
Wide initial measuring ranges reduce the need for retesting.
System detects specimen and reagent levels prior to processing to ensure accuracy of results.
Serial dilution technology supports reliable results and helps to keep the dilution factor low.

Rely on a proven system that is established in the market and built for the future.

The BN II System has an excellent service track record, with an average of 2–3 service visits per year.
Siemens Healthineers has extensive, long-term experience and expertise as an instrument service provider. You can be confident in our support for your lab’s operations.
Our continuous launches of innovative tests and advances in laboratory automation demonstrate our commitment to providing meaningful new solutions for your current and future plasma protein testing needs.

†

Product availability may vary from country to country and is subject to varying regulatory requirements.

Please contact your local representative for availability.

Assays

Plasma protein assay bottles — With assays available for serum, urine, and cerebrospinal fluid, you can conveniently assess numerous disease states on just one system.

The largest specialty protein testing menus available

The BN II System menu includes more than 70 assays, including therapeutic drug monitoring, cardiac risk assessment, kidney diseases, neurological disorders, nutritional assessment, and iron and anemia assessment.

Download the menu for facilities outside the U.S. (pdf) 0.18 MB

Get a complete disease-state picture

Expand to explore the plasma protein portfolio from Siemens Healthineers.

Kidney Disease

α1-Microglobulin urine
α2-Macroglobulin urine¹
ß2-Microglobulin urine
ß-trace protein¹
Albumin urine
Cystatin C
FLC kappa urine¹
FLC lambda urine¹
Ig/Light Chain, type kappa urine¹
Ig/Light Chain, type lambda urine¹
IgG urine
Transferrin urine

Cardiovascular Risk/Acute Cardiac Care

Albumin urine
Apo A-I
Apo B
Cystatin C
Fibrinogen
High Sensitivity CRP (CardioPhase® hsCRP)
Homocysteine
Lp(a)
Myoglobin

Chronic Alcohol Abuse

CDT (Carbohydrate-deficient Transferrin)
Transferrin (for %CDT calculation)

Anemia/Iron Metabolism

Ferritin
Haptoglobin
Hemopexin
sTfR (Soluble Transferrin Receptor)
Transferrin

1

The products/features/applications mentioned here are not commercially available in all countries and are subject to local regulations. Their future availability cannot be guaranteed. Not available for sale in the U.S.

12

Alliance application manufactured by third party, distributed by Siemens Healthcare Diagnostics Inc.

Technical Specifications

Expand to learn more about key specifications.

Measuring principle	Nephelometry; measurement of the scattered light intensity in a fixed angle of 13 - 24 degrees
Methods	More than 70 programmed assay protocols
Sample throughput	Effective: Approx. 130 tests/hour depending on the assay mix Nominal: 225 tests/hour
Analysis method	Fixed-time kinetics, end-point measurement, VLin Integral
Calibration	Multi-point calibration
Rack transport unit	Racks for up to 8 standard or control vials Racks for up to 7 reagent vials Racks for up to 10 sample tubes
Dilution unit	2 frames for max. 264 dilution cups
Size of sample tubes	Diameter: 12 - 16 mm Height: 55 - 100 mm For pediatric samples: Conical microtubes with a maximum filling volume of 1.5 mL
Barcode types	Automatic reading of different barcode types: 2/5 interleaved Codabar Code 39 Code 93 Code 128
Reagent volume	40 µL reagent consumption on average
Sample dilution	1 : 1 to 1 : 160,000
Level detection	For samples, standards, controls, reagents, and system liquid containers
Reaction cuvettes	60 reusable cuvettes
Measuring temperature	37 ± 1.5°C
Light source	Infrared high performance LED
Wavelength	840 ± 25 nm
Detector	Photodiode with integrated pre-amplifier
Instrument dimensions and weight	Analyzer dimensions (W x H with tubings x D) 124 x 92 x 63 cm (49 x 36 x 25 in.) Computer dimensions (W x H x D) Approx. 19.7 x 19.7 x 3.6 cm (7.8 x 7.8 x 1.4 in) Depth with keyboard Approx. 74 cm (29 in.)⁴ Printer dimensions (W x H x D) Approx. 41 x 27 x 37 cm (16 x 11 x 15 in.)⁴ Total bench length Approx. 230 cm (90 in.)⁴ Analyzer weight 150 kg (330 lb.) Terminal weight Approx. 7 kg (15.4 lb.)⁴
Room environment	Ambient temperature 15 to 32 °C (59 to 89 °F) Relative humidity Maintain between 30% and 85% (noncondensing) Average thermal output 340 BTU/hr (100 W) in standby mode 975 BTU/hr (286 W) in operating mode Water requirements Deionized water, NCClS Type 2 Microbial count must not exceed 100 CFU/ml
Electrical installation requirements	Voltage 90–30 V 190–260 V Power consumption <140 VA (stand-by-mode) <400 VA (operating mode) Host interfacing Download and host-query mode
Computer and Printer	Terminal Apple Mac mini Computer Printer Lexmark E260 D or DN or equivalent
Connectivity	RS232 bi-directional host interface Aptio® Automation and FlexLab Automation solutions CentraLink® Data Management System

Download Brochure (pdf)

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1

Product availability varies by country. PROTIS IT Solution is not available for sale in the U.S.

2

Availability varies by country. Not available for sale in the U.S.

3

Not available for sale in the U.S.

4

Dependent on model

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Sold separately

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.